BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRODUCER, ELECTROPHYSIOLOGY

    MDR report key: 11194910 · Received January 19, 2021

    Report

    Report Number
    3005334138-2021-00034
    Event Type
    Injury
    Date Received
    January 19, 2021
    Report Date
    January 19, 2021
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DYB
    PMA / PMN Number
    K061015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS PUBLISHED IN EMBASE, PACE - PACING AND CLINICAL ELECTROPHYSIOLOGY IN AN ARTICLE TITLED "A MODIFIED FLUOROSCOPY PROTOCOL TO MINIMIZE RADIATION EXPOSURE DURING PULMONARY VEIN ISOLATION WITH SECOND-GENERATION CRYOBALLOON" BY MARCUS WIECZ, MD. PULMONARY VEIN ISOLATION (PVI) IS NOW THE INTERVENTIONAL CORNERSTONE FOR CATHETER ABLATION OF ATRIAL FIBRILLATION (AF). AT THE TIME, CRYOBALLOON (CB) ABLATION IS ONE OF THE MOST FREQUENTLY USED ABLATION TECHNOLOGIES FOR PVI: DESIGNED AS A SINGLE SHOT DEVICE, CB CAN REDUCE PROCEDURE LEFT ATRIAL DWELL TIME WHEN COMPARED WITH CONVENTIONAL RADIOFREQUENCY (RF) POINT-BY-POINT PVI. BALLOON-BASED ABLATION SYSTEMS POTENTIALLY OFFER A SIMPLER AND FASTER MEANS OF ACHIEVING PVI THAT, THEORETICALLY, IS LESS RELIANT ON OPERATOR DEXTERITY.1 IN A RECENTLY PUBLISHED META ANALYSIS, CB PVI WAS NONINFERIOR TO RF PVI WITH RESPECT TO SAFETY AND EFFICACY.2 HOWEVER, CB PVI IS GENERALLY ASSOCIATED WITH AN INCREASED RADIATION EXPOSURE COMPARED TO RF ABLATION WHERE CATHETER GUIDANCE CAN BE ACHIEVED WITH THREE-DIMENSIONAL (3D) MAPPING. DURING CARDIAC CATHETER INTERVENTIONS, RADIATION EXPOSURE TO PATIENTS AND STAFF SHOULD BE KEPT AS LOW AS POSSIBLE.7 RECENTLY PUBLISHED STUDIES COULD DEMONSTRATE THAT RADIATION EXPOSURE DURING CB ABLATION PROCEDURES CAN BE MINIMIZED BY OPTIMIZING THE FLUOROSCOPY PROTOCOL AND/OR THE ABLATION STRATEGY WITHOUT COMPROMISING SAFETY AND EFFICACY.8¿10 THE OBJECTIVE OF OUR PROSPECTIVE SINGLE CENTER STUDY WAS A SIMPLIFICATION OF PVI WITH SECOND-GENERATION CB (CB2) TO MINIMIZE RADIATION EXPOSURE WITHOUT INCREASING PROCEDURE-RELATED COMPLICATIONS AND AF RECURRENCES. THE STUDY COMPRISED 180 CONSECUTIVE PATIENTS UNDERGOING CB2 PVI. DURING THE STUDY, THREE INCIDENTS OF VASCULAR ACCESS SITE COMPLICATIONS OCCURRED. DOI: 10.1111/PACE.14102.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91620 INTRODUCER, ELECTROPHYSIOLOGY INTRODUCER DYB ST. JUDE MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other